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Promoting honesty and integrity across our daily actions and interactions, our compliance, privacy, and regulatory professionals provide the guidance and resources to uphold the highest ethical standards.

Clinical Trials Regulatory Administrator

Location: Aurora, CO Additional Locations:
Job Number: 786970 Date posted: 04/25/2019
Description:
Provides regulatory support to the KPCO clinical trials team through collaboration with the research sponsors, clinical research staff, and clinical trials management team. Works in collaboration with the KPCO Clinical Trials Manager, Clinical Trials Business Consultant, clinical trials research team and Clinician Investigators. Coordinates, compiles and maintains all regulatory documentation for clinical trials according to IRB, FDA, sponsor policies as well as with federal and state laws regarding research conduct and documentation. Maintains knowledge of and assures departmental compliance with Good Clinical Practices (GCP) and applicable regulatory requirements. Maintains knowledge of policies and procedures and performs in accordance with the Principles of Responsibilities and applicable regulatory requirements, external laws and accreditation standards. Reports, appropriately, observed fraud or abuse.

Essential Functions:
- Coordinates regulatory activities of all clinical trials being conducted at KPCO.
- Manages the process for ensuring appropriate documentation of all aspects of the clinical trials regulatory process ensuring accuracy and compliance with IRB, FDA, Good Clinical Practices, and federal and state regulations.
- Provides supervision and coordination of all regulatory activities, workflow and regulatory staff.
- Assists Clinical Trials Manager with budgeting and billing for clinical trials processes.
- Coordinates preparation and submission of IRB/RRC applications and modifications.
- Develops, implements, and/or oversees orientation and education of investigators and research study staff in the regulatory process for biomedical research, in compliance with federal and local regulations.
- Coordinates with IHR finance, contracts and grants on invoicing sponsors and maintains clinical trials areements. Maintains, updates and reviews all clinical trials SOPs.
- Develops and maintains knowledge of good clinical practice standards.
- Coordinates other research activities, e.g., federal audits, discussions with investigators and communications with research subjects.
- Oversees iMEDRIS clinical trials tracking and documentation systems.
- Serves as a resource to the institution, research staff and investigators regarding current and developing FDA regulations regarding the participation and protection of human research subjects. Performs other duties as assigned.

Basic Qualifications:
Experience
- Minimum four (4) years of experience with IRB and clinical trials documentation required.
Education
- High School Diploma or General Education Development (GED) required.
License, Certification, Registration
- N/A
 
Additional Requirements:


- Experience in a regulatory environment.
- Outstanding verbal and written communication skills and human relations skills.
- Attention to detail and demonstrated accuracy in written documentation.
- Excellent project management, time management, problem solving and customer service skills.
- Ability to work independently and delegate tasks to others.
- Proficiency in spreadsheets and word processing applications required.
- Occasional travel required.
- Knowledge of GCPs.
- Ability to interpret and apply federal regulations and organizational policies and procedures related to the administration of research activities.
- Strong work group, staff member, team and committee leadership and management skills.
 


Preferred Qualifications:
- Bachelor's degree in public administration or health care related field preferred OR four (4) years of experience in a directly related field.

Primary Location: Colorado,Aurora,Waterpark III 2550 S. Parker Rd. S400 Scheduled Weekly Hours: 40 Shift: Day Workdays: Mon, Tue, Wed, Thu, Fri Working Hours Start: 8:00 AM Working Hours End: 5:00 PM Job Schedule: Full-time Job Type: Standard Employee Status: Regular Employee Group/Union Affiliation: Salaried, Non-Union, Exempt Job Level: Individual Contributor Job Category: Compliance / Privacy / Regulatory Department: Institute for Health Research Travel: No Kaiser Permanente is an equal opportunity employer committed to a diverse and inclusive workforce. Applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy), age, sexual orientation, national origin, marital status, parental status, ancestry, disability, gender identity, veteran status, genetic information, other distinguishing characteristics of diversity and inclusion, or any other protected status.

External hires must pass a background check/drug screen. Qualified applicants with arrest and/or conviction records will be considered for employment in a manner consistent with federal and state laws, as well as applicable local ordinances, including but not limited to the San Francisco and Los Angeles Fair Chance Ordinances.

About Compliance, Privacy & Regulatory Careers

Compliance, Privacy & Regulatory Careers

We've established a comprehensive, world-class compliance, privacy, and regulatory program, giving you the chance to make a difference in the lives of millions. As a member of this team, you'll engage with internal stakeholders to foster an environment of safety and trust for our members, physicians, and employees alike.

Helping to establish and maintain an effective compliance program, you'll ensure that we operate according to the highest ethical standards and follow all applicable laws, standards, policies, and procedures. Everything we do — from developing policies and training to protecting privacy and security — reinforces our commitment to our members, regulators, and the communities we serve.

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